Monday, August 10, 2009

"The sleeping pill Halcion, already banned in Britain and several other countries, is coming under renewed scrutiny in the US.

The Food and Drug Administration's Advisory Committee on Psychopharmacologic Drugs was briefed last week on a new Institute of Medicine report which argues that taking Halcion as recommended causes no serious ill effects. But the report also notes that many Americans are prescribed much higher doses of the drug by their doctors, and the IOM wants the FDA to check for possible problems caused by the drug.

British regulators banned Halcion in 1991 over fears that it could cause psychiatric disturbances."

I guess that FDA is a regulatory agency to approve and make drugs remain as long as possible at US market.Unfortunately many countries with no regulation uses FDA standards giving the agency a great power over the global market.

Sunday, August 09, 2009

There is Vioxx and Celebrex, I know, I know but I don't know about any other.I just came across with the site CenterWatch "recognized by many of the top media outlets and publications around the world as a leading source of information on the clinical trials industry."I was searching for the 4th phase of clinical trials and this site was at the first page. That's how they explain the 4th phase:

"Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study."

Taken from the market? If anybody knows of a drug that was taken from the market because FDA studied it and came to the conclusion that it's not a good drug please let me know.

According to this same site:

"If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug's long-term effectiveness and its impact on the quality of a person's life."

If anybody knows about any site where I can find FDA real surveillance I would also like to know.

"‘Evergreening’ is the term used to describe the process by which the innovator patents trivial modifications of already-existing drugs which, in turn, extends their monopolies beyond the 20-year period granted for the original patent. It is a common practice in the pharmaceutical industry."

FDA and other countries regulatory agencies seems to be much more concerned in keeping the same drugs at the market. I will never understand how a drug that has killed during clinical trial, Cymbalta, is at the market.Tracy Johnson hanging herself at Eli-Lilly's facilities during Cymbalta clinical trials was not enough or perhaps just an anecdotal evidence and not a scientific data.

Update:*It's still at the market! There is a good article at USA Today about how the Vioxx case:

"Sen. Chuck Grassley, R-Iowa, says the FDA was worse than passive. Investigators for the Senate Finance Committee, which Grassley chairs, met Thursday with FDA researcher David Graham, lead scientist on a study presented in August at a medical meeting in France."

"Graham told the finance committee investigators that the FDA was trying to block publication of his findings, Grassley said in a statement. "Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,' " Grassley said. Graham gave Grassley copies of e-mail that appear to support his claims that his superiors suggested watering down his conclusions."

Sunday, August 02, 2009

Many people is visiting this blog searching for this post I wrote about Senator Lyle Hillyard vacations.The picture that was at the Senate site and the copy I had at this blog has disappeared but you can find this little image at Google's search. I have a copy of the photo but I will not publish it.I'm writing this post to explain what has happened to those who come in search for the photography.People are confused if it was a joke, the picture might be a photoshop, or if it's a real photography. I believe that explaining what it's really is about is better than deleting the picture and people are still discussing it at the Senate site where the photo was published without the picture now. The discussion is here.I will take the opportunity to ask Senator Lyle Hillyard to pay attention at the severe harm psych medications are doing with US citizens and how terrible are US mental health hospitals.There are lots of informations at Philip Dawdy's site Furious Seasons in case those who work for the Senator have a time to pay attention to this issue.Senator Charles Grassley is already trying to make some change in the corrupt scheme medicine has became.At this page of his site there is a good example:

July 9, 2009

Grassley, Kohl work to bring transparency to biomedical research funding

"WASHINGTON – Today Senators Chuck Grassley and Herb Kohl sent a letter to the National Institutes of Health (NIH), urging the federal agency to take steps to increase transparency of federally funded biomedical research. NIH is seeking public comment as it considers changes to its disclosure policy, and the senators made specific recommendations related to both individual researchers and academic institutions who receive NIH grants."

"The senators suggested that researchers be required to report their outside income to the nearest $1000, and that universities be required to complete a plan to manage the researcher’s potential conflicts of interest. Finally, they maintained that both the disclosures and the plan be available to the public via the NIH website."

"For the past two years, Grassley and Kohl have collaborated to push for increased transparency in financial relationships between physicians and the drug, device and biologic industries. As part of that effort, they have championed the Physician Payments Sunshine Act (S. 301) to require these industries to publicly report payments and gifts to doctors. Recently, identical provisions to those in S.301 were included in the health care reform discussion documents released by the Senate Finance Committee. Similar provisions were included in the House draft bill as well.Grassley is Ranking Member of the Senate Committee on Finance. Kohl is Chairman of the Senate Special Committee on Aging. Below is the text of their letter to NIH."